SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a - 16 OR 15d - 16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of December, 2006
SkyePharma PLC
SkyePharma PLC, 105 Piccadilly, London W1J 7NJ England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40F.
Form 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _______
For Immediate Release 18 December 2006
SkyePharma PLC
FDA APPROVES FORADIL® CERTIHALER™
LONDON, UK, 18 December 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
announces today that the US Food and Drug Administration (FDA) has approved
FORADIL® CERTIHALER™ (formoterol fumarate inhalation powder) for the
treatment of asthma. FORADIL® CERTIHALER™ has been co-developed by
SkyePharma and Novartis, and is a trademark of Novartis.
The FDA issued an "approvable" letter for FORADIL® CERTIHALER in April 2006.
Following a recall from the German and Swiss markets in January 2006 because
of concerns that accidental mishandling of the device may have resulted in
inaccurate dosing in a small number of cases. The device was modified and the
modifications were submitted to the FDA.
The Foradil® Certihaler™ has been approved in 27 countries outside the USA,
and SkyePharma is in discussion with Novartis with respect to commercial launch
in these territories.
SkyePharma earns a royalty on sales of FORADIL® CERTIHALER™ in all markets.
SkyePharma also manufactures and supplies the FORADIL® CERTIHALER™.
Frank Condella, CEO, SkyePharma said:
"We are extremely pleased by the FDA's decision to approve the modifications to
FORADIL® CERTIHALER™. We believe that this approval validates SkyePharma's
inhalation technology and paves the way to future products."
For further information please contact:
SkyePharma PLC +44 207 491 1777
Frank Condella, Chief Executive Officer
Ken Cunningham, Chief Operating Officer
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court / Rebecca Skye Dietrich
The Trout Group + 1 617 583 1308
Seth Lewis
Notes for editors
About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world-leading
drug delivery technologies that provide easier-to-use and more effective drug
formulations. There are now eleven approved products incorporating SkyePharma's
technologies in the areas of oral, injectable, inhaled and topical delivery,
supported by advanced solubilisation capabilities. For more information, visit
www.skyepharma.com.
Certain statements in this news release are forward-looking statements and are
made in reliance on the safe harbour provisions of the U.S. Private Securities
Litigation Act of 1995. Although SkyePharma believes that the expectations
reflected in these forward-looking statements are reasonable, it can give no
assurance that these expectations will materialize. Because the expectations are
subject to risks and uncertainties, actual results may vary significantly from
those expressed or implied by the forward-looking statements based upon a number
of factors, which are described in SkyePharma's 20-F and other documents on file
with the SEC. Factors that could cause differences between actual results and
those implied by the forward-looking statements contained in this news release
include, without limitation, risks related to the development of new products,
risks related to obtaining and maintaining regulatory approval for existing, new
or expanded indications of existing and new products, risks related to
SkyePharma's ability to manufacture products on a large scale or at all, risks
related to SkyePharma's and its marketing partners' ability to market products
on a large scale to maintain or expand market share in the face of changes in
customer requirements, competition and technological change, risks related to
regulatory compliance, the risk of product liability claims, risks related to
the ownership and use of intellectual property, and risks related to
SkyePharma's ability to manage growth. SkyePharma undertakes no obligation to
revise or update any such forward-looking statement to reflect events or
circumstances after the date of this release.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SkyePharma PLC
By: /s/ Douglas Parkhill
Name: Douglas Parkhill
Title:
Company Secretary
Date: December 18, 2006